(144 days)
Not Found
Not Found
No
The description details a simple in vitro diagnostic device using test strips for visual qualitative results, with no mention of AI or ML technology.
No
This device is described as an "in vitro diagnostic device" for detecting drugs of abuse in urine, which provides diagnostic information, not therapeutic benefit.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine."
No
The device description clearly indicates it is a physical specimen collection cup containing drug test strips, which are hardware components. There is no mention of any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone. The cut-off concentration for each of the available test strip is listed below:
| THC | 11-nor-A 9-THC-9-COOH | 50 | ng/ml |
|---|---|---|---|
| COC | Benzoylecogine | 300 | ng/ml |
| OPI | Morphine | 2000 | ng/ml |
| MET | Methamphetamines | 1000 | ng/ml |
| PCP | Phencyclidine | 25 | ng/rnl |
| AMP | Amphetamines | 1000 | ng/ml |
| BAR | Secobarbital | 300 | ng/ml |
| BZO | Oxazepam | 300 | ng/ml |
| MTD | Methadone | 300 | ng/ml |
Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine. The test is intended for professional and point of care use . This test device in not intended for over the counter sale to lay users.
The NexStp test cup provides only preliminary analytical test results. A more specific atternate chemical method must be used in order to obtained a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Product codes
DKZ, DIO, LDJ, DJG, DIS, JXM, LAF, LCM, DJR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and point of care use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 82001
Mr. Barry M. Tydings President and CEO Drug Free Enterprises, Inc. 1627 S. Granville Avenue - Suite #3 Los Angeles, CA 90025
Re: K012390
Trade/Device Name: Drug Free Enterprises NexStp Drug Check test cup Regulation Number: 21 CFR 862.3100; 21 CFR 862.3870; 21 CFR.3150; 21 CFR 862.3610; 21 CFR 862.3250; 21 CFR.3650; 21 CFR 862.3170; 21 CFR 862.3620 Regulation Name: Amphetamine test system; Cannabinoid test system; Barbiturate test system; Methamphetamine test system; Cocaine and cocaine metabolite test system; Opiate test system; Benzodiazepine test system; Methadone test system Regulatory Class: Class II; Class II, Class II; Class II; Class II; Class II; Class II; Class II; Class II Product Code: DKZ; DIO; LDJ; DJG; DIS; JXM; LAF; LCM; DJR Dated: November 20, 2001 Received: November 20, 2001
Dear Mr. Nunna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) 012390
Device Name: Drug Free Enterprises NexStp Drug Check test cup
Indications for Use:
Prescription Use
Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone. The cut-off concentration for each of the available test strip is listed below:
| THC | 11-nor-A 9-THC-9-COOH | 50 | ng/ml |
|---|---|---|---|
| COC | Benzoylecogine | 300 | ng/ml |
| OP' | Morphine | 2000 | ng/ml |
| MET | Methamphetamines | 1000 | ng/ml |
| PCP | Phencyclidine | 25 | ng/rnl |
| AMP | Amphetamines | 1000 | ng/ml |
| BAR | Secobarbital | 300 | ng/ml |
| BZO | Oxazepam | 300 | ng/ml |
| MTD | Methadone | 300 | ng/ml |
Thomael Smith for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices V-012290 510(k) Number.
Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine. The test is intended for professional and point of care use . This test device in not intended for over the counter sale to lay users.
The NexStp test cup provides only preliminary analytical test results. A more specific atternate chemical method must be used in order to obtained a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) C Over-The-Counter Use ்ட (Optional Format 1-2-96) (Pa 21 CFR801.109)